Brachial Artery t-PA Release in Heart Transplant Recipients (P1A3C)
Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.
This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.
Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.
Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)|
- Peak t-PA release [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
- t-PA release at various doses [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Patients receive 0, 10, 20, and 40 ng/min/100cc forearm volume of intrabrachial bradykinin, for 5 minutes at each dose. Forearm blood flow will be measured by strain gauge plethysmography, blood samples will be obtained to measure t-PA, PAI-1 at each dose. FMD and Radial artery tonometry will also be performed under resting conditions.
Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780637
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||James AS Muldowney, MD||Vanderbilt University|